Bharat Biotech Gets DCGI Approval For Phase III Trials Of Intranasal COVID-19 Vaccine As Booster Dose

On the 28th of January, Friday, the Drug Controller General of India (DGCI) approved Phase III trials of Intranasal COVID-19 vaccine.

It is to be noted, the Hyderabad based Bharat Biotech International Private Limited, also the manufacturer of one of India's COVID-19 vaccines, COVAXIN, applied for Phase III conduct of the Intranasal COVID-19 vaccine, which is likely to be used as booster shots.

The approval to conduct trials of two doses vaccine and booster dose have been granted after studying a report of the same. Initially, on the 5th of January, the Special Expert Committee (SEC) of the DCGI gave 'in principle' approval to Bharat Biotech. Now, weeks after, the DCGI also approved the clinical trials of the intranasal vaccine.

Notably, the Hyderabad based company received the Drug Controller General of India's nod for conducting phase 2 clinical trials of the nasal vaccine in August 2021.

According to sources, the Hyderabad based Bharat Biotech aims to conduct clinical trials on 5,000 subjects (50% vaccinated with Covishield and 50% vaccinated with COVAXIN) in 9 different states. If successful and approved, the Intranasal COVID-19 vaccine would be used as a booster shot.

The DCGI approval for the booster shot trial came at a time when India is reporting a massive surge in the Wuhan virus cases. Besides, its new variant Omicron is also on the rise in India with over 2,000 cases spread in 25 Indian states and union territories.